Regulatory and Compliance
HiTech Health’s experienced and diverse team can support you to meet all your regulatory and compliance requirements, from strategy and planning to dossier writing and submission.
Regulatory Support
HiTech Health can support you in developing a regulatory strategy to ensure key milestones are met on the pathway to clinical and commercial realisation. We can also provide detailed regulatory input, support applications, and assist with filings.
Regulatory strategy and management is a crucial element of clinical development and should be considered as early as possible. HiTech Health’s regulatory experts can work as an extension of your team and guide you through EU, UK, US and Rest of World (RoW) requirements. We can support with the following submissions:
- Investigational New Drug (IND)
- New Drug Application (NDA)
- Biologics License Application (BLA)
- electronic Common Technical Document (eCTD)
- Investigational Medicinal Product Dossier (IMPD)
- Clinical Trial Application (CTA)
- Marketing Authorisation Application (MAA)
Auditing & Compliance
Require support with GMP vendor auditing to support your regulatory activities? Our deeply experienced team of auditors work closely with global clients to perform audits to comply with their regulatory obligation.
HiTech Health provides industry-leading auditing services and is ready to support you with:
- Supplier audits
- Internal audits
- Due diligence audits
- Gap assessments
- Qualified Person (QP) Declaration audits
- Preparing and responding to regulatory or Notified Body inspections